FDA Rule Ensures Regulation Over The Term “Gluten Free”
In recent years, grocery aisles have begun to offer a number of foods that purport to be gluten free. However, there have yet to be any stringent benchmarks that a food has had to meet before it could make that claim. That will all change now, though, as the Food and Drug Administration has issued… read more
Parents Asked By FDA To Report Children’s Medical Device Defects
Children’s medical devices have become increasingly commonplace, but the Food and Drug Administration is concerned that parents might not be adequately prepared to report potential adversity associated with a product. Many parents may find themselves attributing a side effect or some type of error to the child or something that they have done wrong, but… read more
Med Prep Drug Facility Plagued By Safety Risks Is Shut Down
Last year, a fungal meningitis outbreak claimed the lives of numerous citizens from around the country and compromised the safety and health of many more. The Food and Drug Administration ratcheted up their compounding pharmacy regulatory efforts as a result, conducting a series of inspections that even led to 14 recalls. These were issued due… read more
FDA Details The Efforts of Their Latin America Office
A new report finds the Food and Drug Administration talking up the efforts of those personnel responsible for ensuring the safety of products incoming from Latin America. The agency points out that many of the items which we interact with on a daily basis will have at least some ingredients imported from a Latin American… read more
FDA Concerned About Medical Device Hacking
As medical devices become more and more complex, they also may become open to hackers looking to gain access to the device. Such is the fear of the Food and Drug Administration, which has just released a report to Congress seeking to stress the importance of cyber security. In particular, the FDA worries that oversights… read more
Don’t Underestimate The Foodborne Illness Threat
If you pay attention to this blog, you’ll know that we often bring you information related to product recalls issued because of worries about the threat of foodborne illness. If you’re a relatively healthy individual, you might think that such concerns are exaggerated, that after a day of feeling bad you’ll be able to bounce… read more
FDA Official Explains the Prescription Drug Ad Regulatory Process
They’re so prevalent that they’ve become the target of numerous jokes that you might see on late night television: prescription drug ads that feature a voice explaining the potential side effects of a drug as quickly as possible. But while some might scoff about such promotional materials, it’s important to realize that warnings about drugs… read more
FDA Offers New MedWatch Form to Patients
Have you ever been so worried about the side effects of a medical product that you’ve filed an adversity report with the Food and Drug Administration’s MedWatch program? If not, don’t worry, because you’re not alone. For many, the thought never even crosses their minds, and some think the process of filing an adversity report… read more
FDA Warns Ashtma Users of Phaseout of Inhalers That Use CFCs
May has been designated as Asthma and Allergy Awareness Month, and the Food and Drug Administration is using the classification as a platform to inform persons suffering from both asthma or COPD (chronic obstructive pulmonary disease) about an upcoming regulatory deadline that could have an impact on their therapy. By the end of this year,… read more
FDA Explains How Women Can Ensure a Healthy Heart
The Food and Drug Administration has come out with a news release that seeks to explain their various efforts to help women understand how to maintain a healthy heart. In addition to making the general audience aware of the resources available, the agency is also explaining the important steps that can be taken to ensure… read more
Compounding Pharmacy Bill Unanimously Approved By Senate Committee
Safety advocates and lawmakers have grown concerned about a potential loophole in the law that leaves a grey zone in the regulation of compounding pharmacies. Last year, over 700 people became ill and 50 died because they were exposed to contaminated steroid injections from a compounder. To make sure such an incident never happens again,… read more
Food Defense Plan Builder Rolled Out By The FDA
When an outbreak of a foodborne illness stemming from a manufacturing facility occurs, negligence to follow regulatory standards and simple error are typically to blame. But there are also some instances where a manufacturer refuses to acknowledge Food and Drug Administration warnings, or worse, employees knowingly endanger consumers. The FDA has come out with a… read more
